Serious Allergic Reactions Reported with Asenapine Maleate (Saphris)

In slightly less than two years of approval, about 87,000 people have been prescribed asenapine maleate. The FDA’s Adverse Event Reporting System (AERS) has had a significant number of serious allergic (hypersensitivity) reactions reported. These serious allergic reactions were reported in 52 cases and are considered Type 1 hypersensitivity. From the FDA:

“Signs and symptoms of Type I hypersensitivity reactions may include anaphylaxis (a life-threatening allergic reaction), angioedema (swelling of the deeper layers of the skin), low blood pressure, rapid heart rate, swollen tongue, difficulty breathing, wheezing, or rash . . . Several cases reported multiple hypersensitivity reactions occurring at the same time, with some of these reactions occurring after the first dose of Saphris.”

“Saffron petal was significantly more effective than placebo and was found to be equally efficacious compared to fluoxetine and saffron stigma.”

Now, hold on a minute. This is not a good, particularly scientific, study. This is just a review of studies, some of which are very questionable in nature. The above statement is premature at best. All that can really be said (in my opinion) is that saffron deserves further study and that some formulation of it might work.

Why Are People Treated With Many Drugs At Once?

Good question. This is called polypharmacy and most doctors agree it’s a bad thing. The reason polypharmacy is bad is because it greatly increases the chance, and severity, of side effects. (There are other reasons too.) People who have been through rounds of polypharmacy will tell you this is true.

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2 Comments

I was very depressed a week ago. I decided I needed to take something to help me. I didn’t have time to go to my doctor and instead read about some natural alternatives. I’ve never taken an antidepressant so I didn’t know what to expect. I read about saffron and because I had some in my kitchen, I decided to try it. I couldn’t believe how amazing it worked. Within a few days I felt like a new person. I have been going through a bad separation for two years and crying all the time. Now I haven’t cried in a week! I know I’m only one person and not a study, but it really works to stop the pain.